Mild Cognitive ImpairmentNCT01745198
Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Pamlab, Inc. at 1 site in United States.
Trial summary
In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease Related Disorders
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) will be matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group).
Who may be able to join
- With a diagnosis of normal aging (NL), cognitive impairment or dementia not otherwise specified (CI/D), or ADRD
- With at least one previous quantitative MRI (qMRI)
- With at least one previous homocysteine level
- Without homocysteinemia plus no past or current B12, folate or Cerefolin® treatment, OR with homocysteinemia plus past or current Cerefolin® treatment
Who cannot join
- Subjects who do not meet the inclusion criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Memorial Hospital
Newport Beach, California, 92663
About this study
Official title: Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Related Disorders
In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data.
Read the detailed description
CerefolinNAC® is an orally administered prescription medical food, and is formulated as a combination of L-methylfolate calcium (as Metafolin®), methylcobalamin, and N-acetylcysteine. In a retrospective analysis, disease-delaying effects of Cerefolin®/CerefolinNAC® (CFLN) are examined in terms of cognition (measured by MCI Screen (MCIS)), and functional capacity (measured by Functional Assessment Staging Test (FAST)). - the treatment effect of CFLN on cognitive and functional measures, and on biomarker measures in patients with Alzheimer's disease and related disorders (ADRD).
The current study will expand the NAC-002b study dataset by prospectively collecting additional biomarker and imaging data in a more comprehensively assessed, matched sample of patients. This will allow more precise evaluation of cognitive and functional outcome measures, and biomarker measures will be assessed in an attempt to identify specific populations or conditions in which CFLN is most effective.
The sample will consist of patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group). Also 65 additional subjects will be recruited for the non-Treatment group, which will be used to improve the rate of decline estimates for the cognitive and functional outcome measures.
- Keywords
- homocysteinemia, dementia, depression, vitamin B12, folate, mild cognitive impairment, alzheimer's, homocysteine
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Homocysteinemia, Dementia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | This group consists of patients diagnosed with homocysteinemia who have been treated with Cerefolin®/CerefolinNAC® in the past or are currently being treated with Cerefolin®/CerefolinNAC®. | |
| Non-Treatment Group | This group consists of patients not diagnosed with homocysteinemia who have no past or current treatment with Vitamin B12, Folate or Cerefolin®/CerefolinNAC®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of cognitive decline as measured by the Memory Performance Index (MPI)
Change in MPI over time will be calculated using multiple retrospective time points.
Measured: Baseline to end of study (estimated average of 48 months)
Secondary outcomes (7)
Change in rate of cognitive decline as measured by the MCI Screen
Change in MCI Screen over time will be calculated using multiple retrospective time points.
Measured: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings
Change in CERAD drawings over time will be evaluated using multiple retrospective time points
Measured: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by Trails A & B
Change in Trails A \& B over time will be assessed using multiple retrospective time points
Measured: Baseline to end of study (estimated average of 48 months)
Rate of atrophy of hippocampal volume
Decrease in hippocampal volume over time will be assessed using volumetric MRI
Measured: Baseline to end of study (estimated average of 48 months)
Rate of atrophy in cortical volume
Decrease in cortical volume over time will be assessed using volumetric MRI
Measured: Baseline to end of study (estimated average of 48 months)
Rate of atrophy in ventricular volume
Decrease in ventricular volume over time will be assessed using volumetric MRI
Measured: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by Functional Assessment Staging Test (FAST)
Change in FAST over time will be calculated using multiple retrospective time points.
Measured: Baseline to end of study (estimated average of 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamlab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Shankle Clinic, Hoag Memorial Hospital Presbyterian
- Responsible party
- Sponsor
- Investigators
- William R Shankle, MS, MD, FACP, Principal investigator, Shankle Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745198
- Sponsor's protocol ID
- NAC-002c
- Status last verified
- Apr 2015
- First submitted
- 3 Dec 2012
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Related Disorders
- ClinicalTrials.gov ID
- NCT01745198
- Acronym / sponsor ID
- NAC-002c
- Keywords
- homocysteinemia, dementia, depression, vitamin B12, folate, mild cognitive impairment, alzheimer's, homocysteine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Pamlab, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Shankle Clinic, Hoag Memorial Hospital Presbyterian
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data.
Detailed description
CerefolinNAC® is an orally administered prescription medical food, and is formulated as a combination of L-methylfolate calcium (as Metafolin®), methylcobalamin, and N-acetylcysteine. In a retrospective analysis, disease-delaying effects of Cerefolin®/CerefolinNAC® (CFLN) are examined in terms of cognition (measured by MCI Screen (MCIS)), and functional capacity (measured by Functional Assessment Staging Test (FAST)). - the treatment effect of CFLN on cognitive and functional measures, and on biomarker measures in patients with Alzheimer's disease and related disorders (ADRD).
The current study will expand the NAC-002b study dataset by prospectively collecting additional biomarker and imaging data in a more comprehensively assessed, matched sample of patients. This will allow more precise evaluation of cognitive and functional outcome measures, and biomarker measures will be assessed in an attempt to identify specific populations or conditions in which CFLN is most effective.
The sample will consist of patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group). Also 65 additional subjects will be recruited for the non-Treatment group, which will be used to improve the rate of decline estimates for the cognitive and functional outcome measures.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | –This group consists of patients diagnosed with homocysteinemia who have been treated with Cerefolin®/CerefolinNAC® in the past or are currently being treated with Cerefolin®/CerefolinNAC®. |
| Non-Treatment Group | – | –This group consists of patients not diagnosed with homocysteinemia who have no past or current treatment with Vitamin B12, Folate or Cerefolin®/CerefolinNAC®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) will be matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group).
Key inclusion criteria (4 listed)
- With a diagnosis of normal aging (NL), cognitive impairment or dementia not otherwise specified (CI/D), or ADRD
- With at least one previous quantitative MRI (qMRI)
- With at least one previous homocysteine level
- Without homocysteinemia plus no past or current B12, folate or Cerefolin® treatment, OR with homocysteinemia plus past or current Cerefolin® treatment
Key exclusion criteria (1 listed)
- Subjects who do not meet the inclusion criteria will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in rate of cognitive decline as measured by the Memory Performance Index (MPI)
Time frame: Baseline to end of study (estimated average of 48 months)
Change in MPI over time will be calculated using multiple retrospective time points.
7 secondary outcomes
Change in rate of cognitive decline as measured by the MCI Screen
Time frame: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings
Time frame: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by Trails A & B
Time frame: Baseline to end of study (estimated average of 48 months)
Rate of atrophy of hippocampal volume
Time frame: Baseline to end of study (estimated average of 48 months)
Rate of atrophy in cortical volume
Time frame: Baseline to end of study (estimated average of 48 months)
Rate of atrophy in ventricular volume
Time frame: Baseline to end of study (estimated average of 48 months)
Change in rate of cognitive decline as measured by Functional Assessment Staging Test (FAST)
Time frame: Baseline to end of study (estimated average of 48 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William R Shankle, MS, MD, FACP principal investigator
Shankle Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Pamlab, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of cognitive decline as measured by the Memory Performance Index (MPI) (time frame: Baseline to end of study (estimated average of 48 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.